Regulated Medical Device Software Test Engineer

Talentify; Plymouth (MN); On-site; USD 69,000 - 83,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Time Off (PTO)

Job summary

Actalent is seeking a Software Test Engineer in Plymouth, MN, to execute system-level verification for a regulated medical device platform. The role involves hands-on testing on embedded hardware, script authoring, and audit-ready documentation within a DHF framework.

The candidate will develop and execute test plans, ensure traceability from requirements to results, and collaborate with engineering, quality, and regulatory teams to ensure compliance and product safety.

Qualifications

• Minimum 2 years of software testing/verification experience.
• Experience writing test scripts for regulated software/systems.
• Hands-on authoring of verification documents beyond formatting tasks.
• Comfort with DHF documentation in a regulated environment.

Responsibilities

• Author system-level verification test scripts and protocols using ALM-based processes.
• Install and configure software releases on embedded hardware platforms.
• Execute scripted and exploratory verification testing to validate requirements.
• Maintain end-to-end traceability between requirements, tests, and results in ALM/DOORS.
• Collaborate with software engineers to ensure adequate test coverage and test readiness.
• Prepare VRRs and verification summaries for regulatory and quality records.
• Support audit readiness by ensuring complete, consistent verification documentation.

Skills

Test scripting

Verification

Documentation

Attention to detail

Education

Bachelor's degree in Engineering, CS, or related

Tools

ALM

DOORS

PrisMax

C++

Google Test

Job description

Actalent is seeking a Software Test Engineer in Plymouth, MN, to execute system-level verification for a regulated medical device platform. The role involves hands-on testing on embedded hardware, script authoring, and audit-ready documentation within a DHF framework.

The candidate will develop and execute test plans, ensure traceability from requirements to results, and collaborate with engineering, quality, and regulatory teams to ensure compliance and product safety.